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FDA Recalls

October 2001 - August 7, 2002

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 7, 2002:

CLASS II

MANUFACTURER: Philips Medical Systems, Nederland B.V. Netherlands. Firm initiated recall is complete. Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated October 26, 2001.

PRODUCT: 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremeties. These images and/or spectra, when interpreted by a trained physician, yeild information that may assist in diagnosis. The coils are used to obtain optimal imaging. Recall # Z-1147-2.

REASON: Higher than expected current in the insulation of the coil cable.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 26, 2002:

CLASS II

MANUFACTURER: Toshiba America Medical Systems, Inc., Tustin, CA, by letters dated February 22, 2002. Firm initiated recall is ongoing.

PRODUCT:NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2.

REASON: Software anomally caused error in calculating VM_P.

MANUFACTURER: Nellcor Puritan Bennett, Ireland, Ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2.

REASON: Failure of optional compressor on ventilator.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 19, 2002:

CLASS II

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letters sent March 28, 2002. Firm initiated recall is ongoing.

PRODUCT:STERRAD 100S Sterilization System. Recall # Z-1082-2.

REASON: Software anomaly allows half cycle run when full cycle displayed.

MANUFACTURER: Gimelli Laboratories Co. Ltd., Shenzen Bao'An, Guangdong. Firm intiated recall is ongoing.

PRODUCT: Interplak power plaque remover toothbrush, battery operated toothbrush used to brush teeth and remove plaque.
Recall # Z-1104-2.

REASON: Batteries leaking hydrogen gas during charging popping off the end cap.

CLASS III

MANUFACTURER: Essex Industries, Inc., St. Louis, MO, by fax on February 22, March 26 and April 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Invacare IRC 2121 Select Flow, CGS 870, 0-6L medical oxygen regulators. Recall # Z-1103-2.

REASON: Mislabeled as 0-6 LPM rather than 0-8 LPM.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 12, 2002:

CLASS II

****CORRECTION****

Recall # Z-1030-2 originally published in Enforcement Report 02-19 had an
incorrect recalling firm and notification date listed. It was listed as
Gambro Healthcare on April 9, 2000. The correct firm is Gambro Renal
products on April 9, 2002.

MANUFACTURER: I-Stat Corp., East Windsor, NJ, by letter dated April 22, 2002. Firm initiated recall is ongoing.

PRODUCT: Hematocrit and creatinine tests, as part of the i-STAT in-vitro diagnostic test system. Field Correction affected cartridges: i-STAT 6+, E3+, EC4+, EC6+, EC8+. Recall cartridges: Crea. Recall # Z-1083-2/Z-1087-2.

REASON: Erroneously high hematocrit results generated with cartridges.

MANUFACTURER: Unipath Ltd., Bedford, the United Kingdom. Firm initiated recall is ongoing. Recalled by Medpointe, Inc. (Wampole Laboratories Division), Cranbury, NJ, by fax on March 15, 2002.

PRODUCT: Clearview HCG II Pregnancy Test, Recall # Z-1089-2.

REASON: Sensitivity deterioration of pouched PRODUCT.

MANUFACTURER: Mitek products, Norwood, MA, by letter between January 17 and 18, 2002. Firm initiated recall is complete.

PRODUCT: Mitek Clearfix Meniscal Screw, 2 mm x 10 mm.
Recall # B-1090-2.

REASON: Meniscal screw may be out of specification and not deploy properly.

MANUFACTURER: Life-Tech Intl., Inc., Stafford, TX, by letter dated February 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Brand name: Uropump Tube, Uropump Damping Chamber.
Recall # Z-1091-2/Z-1096-2.
The tube and chamber are sold stand-alone and in four kits, the Uropump Starter Kit, the Cavernosometry Starter Kit, and two different configurations of the Instrument Set Up Kit. When sold stand alone, the UPT is sold in a box of 50, and the UPDCC in a box of 25.

REASON: Device may not be sterile.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by urgent recall correction notification n April 24, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Affinity Three birthing bed.
Recall # Z-1097-2.

REASON: Bed may change position on its own.

MANUFACTURER: Heartport, Inc., Redwood City, CA, by letters on April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: HEARTPORT Brand Arterial Cannulas described as follows:
Endo Return, 21 Fr.
Endo Return, 23 Fr.
Direct Flow, 24 Fr.
StraightShot, Angled, 23 Fr.
Arterial, 19 Fr. Recall # Z-1098-2/Z-1102-2.

REASON: A lap joint in certain arterial cannulas can separate.

CLASS III

MANUFACTURER: Stryker Trauma SA, Geneva, Switzerland. Firm initiated recall is complete.

PRODUCT: a) Monotube Triax Carbon Tube 15x200mm, Yellow, used for the stabilization of open and/or unstable fractures. Recall # Z-0769-2;
b) Monotube Triax Carbon Tube 15x150mm, Yellow.
Recall # Z-0770-2.

REASON: 200mm monotube length package actually contains a 150mm length monotube.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, the United Kingdom. Firm initiated recall is ongoing.

PRODUCT: VITROS Immunodiagnostics. Recall # Z-1088-2.
Free T3 Reagent Packs for in vitro diagnostic use.
100 test units per pack.

CAT 131 5589
Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, the United Kingdom.

REASON: Failure to include Supplemental Info. Sheet that contains updated values for Free Thyroid Control lots 60, 70 & 80.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 5, 2002:

CLASS I

MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA, by letter on March 12, 2002. FDA initiated recall is ongoing.

PRODUCT: LTV Series Ventilators. Models:
a) LTV 1000 (cat. no. 10130), Recall # Z-1047-2;
b) Model LTV 950 (cat. no. 10950), Recall # Z-1048-2;
c) Model LTV 900 (cat. no. 10638), Recall # Z-1049-2;
d) Model LTV 800 (cat. no. 11800), Recall # Z-1050-2.

REASON: Shorts to inoperative condition.

CLASS II

MANUFACTURER: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.

PRODUCT: Ti Cann Troch Fixation Nail. Trochanteric Fixation Nail. Recall # Z-1056-2/Z-1066-2.

REASON: Hole not properly centered.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter beginning on April 30, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Horizon P100705 monitor slide. Recall # Z-1067-2.

REASON: Monitor may fall.

MANUFACTURER:Ballard Medical Products, Pocatello, ID. Firm initiated recall is ongoing.

PRODUCT:
a) Ballard Express Pre-Assembled Biliary Stent Systems. Recall # Z-1068-2;
b) Ballard Standard Biliary Stent Sets with and without guide wire. Recall # Z-1069-2;
c) Ballard Holland Biliary Stent Sets with and without guide wire. Recall # Z-1070-2;
d) Ballard Pancreatic Stent Sets with and without guide wire. Recall # Z-1071-2;
All sets are packaged in sterile 1-each package.

REASON: Stent anchor wings may not project, thereby failing to anchor stent.

MANUFACTURER: Portex, Inc., Keene, NH. Firm initiated recall is ongoing. Recalled by Sims Portex, Inc., Keene, NH, by letter on May 3, 2002.

PRODUCT: Portex Tracheostomy Tube, Laryngectomy tube, and Nasopharyngeal Airway products as follows:
Flex D.I.C.(TM) Trach Tubes, Product Number 504070 504080 504090 505070 505080 505090 505100. Recall # Z-1072-2;
D.I.C.(TM) Trach Tubes Product Number 502060 502080 502090 503060 503070 503080 503090 503100 512060 512080 512090 513070513080. Recall # Z-1073-2;
Laryngectomy Tube Product Number 562090. Recall # Z-1074-2;
Nasopharyngeal Airway Product Number 340060 340070 340080 340090. Recall # Z-1075-2;
Pediatric Trach Tubes Product Number 555030 555035 555040 555050 555055. Recall # Z-1076-2;
Per Fit (R) Percutaneous Trach Tubes Product Number 522070 522080 522090. Recall # Z-1077-2;
Lo Profile Trach Tube Product Number 592070. Recall # Z-1078-2;
Blue Line(R) Trach Tubes Product Number 508070 518070 518090 521070 521080 521090 530060 530070 530080 530090 531080 531100 550060 550070 550080 550090. Recall # Z-1079-2.

REASON: Product package may have defective seals and compromise sterility of device.

MANUFACTURER: Philips Medical Systems, fka: Picker International, Inc., Highland Heights, OH, by letter on April 8, 2002. Firm initiated recall is ongoing.

PRODUCT: AXIS/IRIX Gamma Camera System. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System. Recall # Z-1080-2. Several catalog and serial numbers.

REASON: If the patient table is lowered onto a nearby object, such as a gurney, it may cause it to tip over.

CLASS III

MANUFACTURER: Arlanda Medicinska Instrument Co. AB, Sollentuna.
Firm initiated recall is complete.
Recalling Firm:
INRAD, Inc., Kentwood, MI, by telephone on April 18, 2002.

PRODUCT: INRAD brand Express core biopsy device, single use, disposable, sterile; 18 gauge x 15 cm. Catalog # 901518. Recall # Z-1081-2.

REASON: Extended expiration date on outer carton.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 29, 2002:

CLASS II

MANUFACTURER: EBI, l.p., Parsippany, NJ, by voluntary recall on March 6, 2002. Firm initiated recall is ongoing.

PRODUCT: EBI XFIX DFS OptiROM Elbow Fixator. Recall # Z-1035-2. The product is sold non-sterile and is packaged either in an inner foam liner aluminum metal casing or in plastic bag.

REASON: Pin migration at the connection of OptiROM central body and fixator.

MANUFACTURER: Genzyme Biosurgery, a division of Genzyme Corp., Fall River, MA, by letter dated April 3, 2002. Firm initiated recall is ongoing.

PRODUCT: Seprapack-Unilateral Application, sterile. (Bioresorbable nasal packing and sinus stent).

Recall # Z-1038-2.

REASON: Product packaging may have voids in the seal compromising sterility of device.

MANUFACTURER: Fisher Diagnostics Middletown, VA. Firm initiated recall is ongoing.

PRODUCT: Bayer Immuno 1(R) Troponin I Method.

Recall # Z-1039-2.

Common Name: Immuno 1(R) Troponin I Method.

REASON: Complaints received of low recoveries on Immuno 1 Troponin I Reagent Lot V60275.

MANUFACTURER: Nellcor Puritan Bennett Ireland, ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2.

REASON: Failure of optional compressor on ventilator.

MANUFACTURER: Hewlett Packard Company, Loveland, CO. Firm initiated recall is ongoing.

PRODUCT: a) Lightcycler microchemistry analyzer, catalog number

011468, printers. Recall # Z-1041-2;

b) Lightcycler microchemistry analyzer, catalog number 2043912, printers. Recall # Z-1042-2;

c) Lumi Imager microchemistry analyzer, catalog number 2012847, printers. Recall # Z-1043-2.

REASON: Printer power cord poses a shock hazard.

MANUFACTURER: ReGen Biologics, Inc., Redwood City, CA, by letters on April 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Linvatec brand Double-Armed, Straight, Trocar Point 13” (33cm) Suture Needle Polyester, Green Braided, 36” (91.4cm) 2-0 U.S.P 3.0. metric. Recall # Z-1044-2.

REASON: Sterility may be compromised.

MANUFACTURER: Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, by letter dated April 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Synapse Image and Information Management System.

Recall # Z-1045-2.

REASON: Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped.

MANUFACTURER: Liebel-Flarsheim Co., Cincinnati, OH. Firm initiated recall is ongoing.

PRODUCT: Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2.

REASON: Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID.

MANUFACTURER: Stryker Corp., Kalamazoo, MI, by letter dated April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Stryker Secure II hospital beds with an optional 110V outlet box assembly. Recall # Z-1055-2.

REASON: Shock hazard.

MANUFACTURER: Hemaedics, Inc., Brentwood, CA. Firm initiated recall is ongoing.

PRODUCT: Duoflo, Applicator Dispenser Kit, with Tisseal VH, Fibrin Sealant. Recall # Z-1053-2.

REASON: Tip breakage into surgical site.

CLASS III

MANUFACTURER: MPC/Geneva Medical Products, Prairie Du Chien, WI. Firm initiated recall is complete.

PRODUCT: a) 3T vent valves for perfusion circuits; sterile.

Recall # Z-1036-2;

b) 3T vent valves for perfusion circuits; non-sterile.

Recall # Z-1037-2.

REASON: Inadequate bond allows blood leakage or separation during use.

MANUFACTURER: Fuji Photo Optical Co. Ltd., Omiya, Saitama, 300-0036, Japan. Firm initiated recall is complete.

PRODUCT: EB-250S and EB-450S bronchoscope.

Recall # Z-1051-2/Z-1052-2.

REASON: During brochoscopy, suction valve stuck in active position.

MANUFACTURER: Dadson Mfg. Corp., Grain Valley, MO. Firm initiated recall is ongoing.

PRODUCT: Padgett Instruments, Inc. roller cylinder for the Mesh Skin Graft Expander, Model P-170, for use in producing a honeycomb pattern on the graft so it will expand. Recall # Z-1054-2.

REASON: The roller assembly might be defective.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 22, 2002:

CLASS II

MANUFACTURER: Invacare Corp., Elyria, OH, by certified mail on April 9, 2002. Firm initiated recall is ongoing.

PRODUCT: Invacare Reliant Scales, Models RSC600 and RSC600E. Recall # Z-1032-2/Z-1033-2.

REASON: The bolts that hold the scale to the lift may break and cause patient injury.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 15, 2002:

CLASS II

MANUFACTURER: Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2.

REASON: Collapsable Holding Chamber inadvertently opening.

MANUFACTURER: Amira Medical, Scotts Valley, CA. Firm initiated recall is ongoing. Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by addendum to labeling beginning December 17, 2001.

PRODUCT: Amira AtLast brand Blood Glucose Test System.

Recall # Z-0999-2.

REASON: Alternate site results not reliable when patient blood glucose level is low.

MANUFACTURER: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing. Baxter Healthcare Corp., Round Lake, IL, by letters dated February 13, 2002.

PRODUCT: Baxter Interlink Solution Sets and Baxter Interlink Secondary Medication Sets which contain the BD Interlink Lever Lock Cannula; these sterile fluid paths are used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. 48 units per case. Recall # Z-1000-2/Z-1007-2.

REASON: Fluid leaks associated with BD Lever Lock cannulas.

MANUFACTURER: Siemens Medical Solutions, Erlangan, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on May 14, 2001.

PRODUCT: Somatom

Esprit, Esprit+, Balance, Emotion, Emotion Due, Volume Zoom, and Volume Access. Recall # Z-1010-2.

REASON: Errors occurring while using graphics tools.

MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, CA, by telephone on March 12, 2002 and by letters on March 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Steri-Oss Replace Select TiUnite Implant.

Recall # Z-1011-2.

REASON: Labeling mix-up.

MANUFACTURER: Laerdal Medical, Stavanger, Norway. Firm initiated recall is ongoing. Recalling Firm: Laerdal Medical Corp., Wappingers Falls, NY, by letters on March 29, 2002.

PRODUCT: Pressure Regulator Assembly (Cat. No. 85).

Recall # Z-1012-2.

This is a component part used in Infant and Child models of the Laerdal Silicone Resuscitator (LSR). It is also distributed in replacement patient valve assemblies, and as individual spare parts.

REASON: Molding irregularity in Pressure Regulator Cap, which could impede free movement of valve stem.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by notification on April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Resident low bed, model 872.

Recall # Z-1014-2.

REASON: Pinched cables may cause arcing/shock hazard.

MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA, by fax and e-mail on April 2, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Model No. 105-5060 1.5 French FlowRider Micro Catheter. Recall # Z-1016-2;

b) Model No. 105-5063 1.8 French FlowRider Micro Catheter. Recall # Z-1017-2;

c) Model No. 105-5067 1.5 French FlowRider Plus Micro Catheter. Recall # Z-1018-2;

d) Model No. 105-5068 1.8 French FlowRider Plus Micro Catheter. Recall # Z-1019-2.

The difference between a FlowRider and FlowRider Plus is the presence of a silicone lubricant in the lumen of the FlowRider, which is, absent in the Plus.

REASON: Catheter rupture.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by a workaround issued on April 1, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory Information System, Versions 5.23 and 5.3. Recall # Z-1020-2.

REASON: No QA Checking Performed on Differential Results.

MANUFACTURER: Longwell Electronics, Inc., Brea, CA. Firm initiated recall is ongoing. Beckman Coulter, Inc., Brea, CA, by product safety alert dated April 18, 2002.

PRODUCT: HP InkJet Printers connected as an accessory to a Beckman Coulter. Recall # Z-1022-2.

REASON: Printer Power Cord may cause shock to lab personnel.

MANUFACTURER: Medtronic Mexico, S. Del R.L. de C.V. Tijuana, BB. Firm initiated recall is ongoing. Medtronic Perfusion Systems, Minneapolis, MN, by, Urgent field action notice dated April 10, 2002.

PRODUCT: Medtronic Intersept Custom Tubing Packs.

Recall # Z-1023-2/Z-1029-2.

The packs are custom assembled for hospitals and each is identified with a product number. The product numbers and hospitals or distributors, for which the packs were assembled, are identified below:

Product number 0V67R10. Recall # Z-1023-2;

Made for: MERCY HOSPITAL, Des Moines, IA

Product number 1H22R2. Recall # Z-1024-2;

Made for: EXTRACORPOREAL ALLIANCE, Port Huron, MI

Product number 1H23R5. Recall # Z-1025-2;

Made for: EXTRACORPOREAL ALLIANCE, Pontiac, MI

Product number 1P82R3. Recall # Z-1026-2;

Made for: EXTRACORPOREAL ALLIANCE, Dearborn, MI

Product number 2D68R2. Recall # Z-1027-2;

Made for: PROVIDENCE MEDICAL CENTER, Kansas City, KS

Product number 2D81R. Recall # Z-1028-2;

Made for: COMPREHENSIVE PREFERRED CARE SVR, Buffalo, NY

Product number 5778R19. Recall # Z-1029-2.

Made for: HEALTH MIDWEST, Kansas City, MO

REASON: The vent valves in the recalled tubing packs may leak blood during cardiopulmonary bypass surgery, or the parts of the valves may separate, due to inadequate glue application.

MANUFACTURER: Gambro Dasco S.p.A. 41036, Medolla, Italy. Firm initiated recall is ongoing.

PRODUCT: Gambro Phoenix Hemodialysis System. Recall # Z-1030-2.

REASON: Incorrect measurement of dialysate conductivity due to electronic comp. failure.

CLASS III

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by telephone on September 20, 2001. Firm initiated recall is complete.

PRODUCT: BD MST Accessory Kit. Recall # Z-0997-2.

REASON: Kits labeled as containing 16 GA introducer actually contained 20 GA introducer.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by visit on March 6, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-1008-2.

REASON: Donor did not meet current guidelines regarding behavioral/social history.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on March 8, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-1009-2.

REASON: Donor did not meet current guidelines regarding behavioral/social history.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Cardiff. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostics CEA (carcinoembryonic antigen) Calibrators. Recall # Z-1013-2.

REASON: Calibration failures/shift in QC results.

MANUFACTURER: Bioenterics Corp., Carpinteria, CA, by telephone on March 29, 2002 and by letters dated April 1, 2002. Firm initiated recall is complete.

PRODUCT: LAP Band

Sterile, Lap-Band Adjustable Banding System, 9.75cm and 10.0cm sizes. PMA# P000008 dated 6/5/01.

Recall # Z-1015-2.

The Lap-Band System is an inflatable silicone band that is laparoscopically placed around the upper part of the stomach to restrict how much food can be eaten at one time. It is indicated for use in weight reduction of severely obese patients.

REASON: Does not conform to PMA re: labeling.

MANUFACTURER: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete. Recalling Firm: Gambro Healthcare, Deland, FL, by telephone on May 26 and 27, 1999, and letter dated June 1, 1999.

PRODUCT: 2-K AC-2409-D acid concentrate and bicarbonate dialysate, 55 Gallons, calcium 2.50 meq/l, etc.

Recall # Z-1021-2.

REASON: Calcium Concentrate was higher than the specified range.

MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letters on April 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Aeroset Cholesterol Reagent. Recall # Z-1031-2.

REASON: Stability may be compromised over time, product currently OK.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 8, 2002:

CLASS II

*****CORRECTIONS*****

In the 02-06, February 13, 2002 Enforcement Report, Recall of Datascope Profile 8 French Intra-Aortic Balloon Catheters, PRODUCT numbers 0684-00-02971-01, 0684-00-0299-01, 0884-00-3441-01, and 0884-00-3441-02, has been assigned recall numbers Z-0518/0521-02.

In the 02-17, May 1, 2002 Enforcement Report, Recall of the Femoral Head Implant from the Foundation Hip System: Labeled in part:

"FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics",

Recall numbers Z-0895-2/Z-0899-2 was listed as ongoing, and should be listed as complete.

Recall of Invacare Mobilare Concentrators, 5 Liter, serial numbers 94K thru 94L, 95A thru 95L, 96A thru 96L, Recall numbers Z-0198-2/Z-0201-2 was originally listed as complete. It should be listed as ongoing.

MANUFACTURER: Invitrogen Corp., Grand Island, NY, by letters dated December 21, 2001. Firm initiated recall is ongoing.

RODUCT: GIBCO *** AIM-V Medium, for ex vivo activation of lymphocytes

-with L-glutamine

-with streptomycin @50 mcg/mL

-with gentamicin sulfate, USP @ 10 mcg/mL

-without penicillin G sodium. Recall # Z-0918-2.

Label states: "Check for product appearance before use. The performance characteristics of this product have not been officially established. It has not been approved to date for any human or animal in vivo applications except for certain investigational studies. ***"Sold in 1000 ml bottles and in 10L bags

REASON: Media fill failures.

MANUFACTURER: Ethicon, Inc., Juarez, Mexico. Firm initiated recall is complete. Ethicon, Inc., Somerville, NJ, by letters on February 10, 2002.

PRODUCT: Sterile Ethicon Gut Sutures. Recall # Z-0919-2-0921-2.

Brand Label: Chromic Surgical Gut Suture Plain Surgical Gut Suture Plain Fast Absorbing Suture

REASON: Secondary packaging has overwrap seal anomaly.

MANUFACTURER: Abbot Health PRODUCTs, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing. Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico, by letters dated March 26, 2002.

PRODUCT: a) AxSYM Digoxin II. Recall # Z-0956-2;

b) TDx/TDxFLx Digoxin II. Recall # Z-0957-2;

c) IMx Digoxin. Recall # Z-0958-2.

REASON: Assay may exhibit negative interference from aldosterone inhibitors.

MANUFACTURER: Medex, Inc., Dublin, OH, by telephone and fax beginning December 17, 2001. Firm initiated recall is ongoing.

PRODUCT: Medex Three-Way Anesthesia Style Stopcock with 20 inch, 33 inch, and 40 inch Extensions with Male Luer Locks and Male Luer Slips. Recall # Z-0986-2/Z-0990-2.

REASON: The tubing may separate from the stopcock during patient use.

MANUFACTURER: Sigma International Medina, NY, by letters between March 21 and 28, 2002. Firm initiated recall is ongoing.

PRODUCT: Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2.

REASON: Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr.

MANUFACTURER: Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2.

REASON: Collapsable Holding Chamber inadvertently opening.

CLASS III

****CORRECTION****

In the 02-17 Enforcement Report, Hydroview Brand Intraocular

Lens, Posterior Chamber Lenses, various diopters. Model Number H60M, Lot

Numbers 5YXP and 6R4B, Recall number Z-0933-2 was listed as ongoing and

should be listed as complete.

MANUFACTURER: Abbott Health PRODUCT, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: Prolactin Calibrators, Prolactin Controls, AxSYM and IMx Prolactin Reagents. Recall # Z-0950-2/Z-0953-2.

REASON: The concentration of Prolactin may have decreased by approx. 20%.

MANUFACTURER: Inrad, Inc., Kentwood, MI, by letter on February 16, 2000. Firm initiated recall is terminated.

PRODUCT: Inrad brand 2 part CHIBA type needle with accumark sheath, 15 cm., sterile. Recall # Z-0996-2.

REASON: 20 cm needle labeled as 15 cm needle.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 1, 2002:

CLASS I

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Hill-Rom bassinet with dropleaf work surface & chart rack; Model 248. Recall # Z-0837-2;

b) Hill-Rom Clinical bassinet with dropleaf work surface & chart rack; model 1251. Recall # Z-0838-2.

REASON: Drop leaf work surface may fall down; won't support infant.

CLASS II

MANUFACTURER: Encore Orthopedics, Inc., Austin, TX, by telephone on August 16, 2001. Firm initiated recall is ongoing.

PRODUCT: The products are the femoral head implant from the Foundation Hip System. The products are labeled in part: "FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics". Each femoral head is packaged individually and labeled sterile.

Recall # Z-0895-2/Z-0899-2.

REASON: Femoral head component may fail.

MANUFACTURER: Smith & Nephew, Inc., Largo, FL, by letter on August 28, 2001. Firm initiated recall is complete.

PRODUCT: Covrsite Brand Wound Dressing, Part Numbers 59714100, 59714000 and 59714400. Recall #Z-900-2/Z-902-2.

REASON: Product was a wound dressing not adhering correctly.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by letter on November 5, 2001. Firm initiated recall is ongoing.

PRODUCT: Optetrak Finned Cemented Tibial Tray (Total Knee Joint Replacement-tibial tray component). The device is intended to be implanted during a knee joint replacement surgery. Recall # Z-0903-2/Z-0904-2.

REASON: Device packaging may be mislabeled with the wrong size parts.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on November 9, 2001. Firm initiated recall is ongoing.

PRODUCT: Raptor Rail PTCA Balloon Dilitation Catheter Catalog Numbers RR115, RR215 and RR315.

Recall # Z-905-2/Z-907-2.

REASON: Some of these catheters had a slower than desired deflation or no deflation.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone, fax and letters on December 17, 2001. Firm initiated recall is ongong.

PRODUCT: Exactech Brand Bipolar Hip Prosthesis, intended for use as an endoprosthesis in hemi-hip arthroplasty procedures.

a)Catalog # BP-2843, 43 mm OD Bipolar, 28mm ID,

Recall # Z-909-2;

b)Catalog # BP-2844, 44 mm OD Bipolar, 28mm ID,

Recall # Z-910-2.

REASON: The locking ring on the components is potentially assembled backwards.

MANUFACTURER: Ossur hf., Iceland. Firm initiated recall is ongoing.

OSSUR North America, Aliso Viejo, CA, by letters on February 27, 2002.

PRODUCT: Icelock ratchet UX 721, Model L-721000.

Recall # Z-0913-2.

Designed for use with ICEROSS silicone upper extremity liners for upper extremity amputees.

REASON: Pin does not stay engaged in lock mechanism.

MANUFACTURER: Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory Microbiology Module,

Recall # Z-0916-2.

REASON: Software does not allow comments to be shown in some reports.

MANUFACTURER: Hitachi Ltd., Kbaraki-ken, Japan. Firm initiated

recall is ongoing.

PRODUCT: Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2.

REASON: Possibility of false negative and false positive results being reported.

MANUFACTURER: Stryker Trauma GmbH D24232 Schoenkirchen, Germany. Firm initiated recall is complete.

Recalling Firm: Howmedica Osteonics Corp., Allendale, NJ, by letter on December 3, 2001.

PRODUCT: Condyle Screw Nut 1 x 05mm. Recall # Z-0927-2.

REASON: Torque on the condyle nut onto the condyle screw may be high. As a result the required compression of condyle fragments is not possible.

MANUFACTURER: Howmedica Osteonics Corp., Rutherford, NJ, by letters dated October 29, 2001.

Stryker Trauma GmbH D24232 Schoenkirchen, Germany.

Firm initiated recall is complete.

PRODUCT: Gamma Nail System Common Name: Gamma Locking Nail-Cross Locking Screws. Recall # Z-0928-2/Z-0929-2.

REASON: Mislabeling of the screw length on the outer package.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone and letters on May 21, 2001. Firm initiated recall is complete.

PRODUCT: Total Knee Augnentation Block Implants.

Recall # Z-0931-2.

REASON: Compromise of sterility barrier packaging.

MANUFACTURER: Medtronic Xomed Jacksonville, FL, by telephone and fax August 30, 2001. Firm initiated recall is ongoing.

PRODUCT: Laser Guard Endotracheal Tube Protector.

Recall # Z-0932-2.

REASON: The Endotracheal Tube Silver Foil wrap may develop breaks when manipulated. Potential for overheating or fire.

MANUFACTURER: Ecolab Inc., Huntington, IN, by letter dated January 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Cida-Steryl 28 II 3% Glutaraldehyde.

Recall # Z-0935-2.

REASON: May not effectively sterilize devices.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: BX Velocity Balloon Expandable Stent, (common name is Coronary Stent and Delivery System, 8mm X 2.75, Sterile. Recall #Z-0936-2.

REASON: Stents could migrate from their original crimped position on the delivery system.

MANUFACTURER: Cardiodynamics International Corp., San Diego, CA, by letter the week of January 14, 2002. Firm initiated recall is complete.

PRODUCT: BioZ.com Hemodynamic Monitor Impedance Plethysmograph.

Recall # Z-0937/Z-0938.

REASON: Improper responses with pacemaker patients.

MANUFACTURER: Recalling Firm: Pentax Precision Instrument Corp.,

Orangeburg, NY, by letters dated March 14, 2002.

Firm initiated recall is ongoing.

PRODUCT: a) Video Bronchoscope, Model EB-1530T3, Device Listing #A845585. Classification: EOQ, Bronchoscope, CFR 874.4680. Recall # Z-0939-2;

b) Video Gastroscope, Model #EG-1540, Device Listing #A845591. Classification: FDS, Gastroscope, CFR 876.1500. Recall # Z-0940-2.

c) Video Esophagoscope, Model #EE-1540, Device Listing #A845597. Classification: GCL, Esophagoscope, CFR 876.1500. Recall # Z-0941-2.

REASON: Lubricant leaking from bronchoscope caused by puncture at the point where the instrument channel is secured to the distal end.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated April 2002. Firm initiated recall is ongoing.

PRODUCT: Recall # Z-0942-2/Z-0946-2.

a) Hill-Rom brand TranStar Electric Stretcher;

b) Hill-Rom brand TranStar OB/GYN Stretcher;

c) Hill-Rom brand TranStar Procedural Stretcher;

d) Hill-Rom brand TranStar Surgical Stretcher;

e) Hill-Rom brand TranStar Trauma Stretcher;

f) Hill-Rom brand Durastar Hydraulic Stretcher.

REASON: May leak hydraulic fluid.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter on April 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom Exam Plus lights, catalog numbers P965-00 and P965-01. Recall # Z-0947-2/Z-0948-2.

REASON: Incorrectly labeled for use during surgical Procedures.

MANUFACTURER: Steris Corp., Mentor, OH, by telephone on March 19 and 20 and by letter on March 21, 2002. Firm initiated recall is ongoing.

PRODUCT: Double Port Flow Adapter, STERIS Part Number 200388.

Recall # Z-0949-2.

1) Sold as a component of STERIS Quick Connect Kit #C1460;

2) Also sold individually as a replacement component.

REASON: Adapter ports may be obstructed with glue, and affect the sterilization process.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated March 29, 2002. Firm initiated recall is ongoing.

PRODUCT: Omni-Diagnost X-Ray System, fluoroscopic x-ray system: multifunctional, universal, overtable x-ray system offering fluroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. Recall # Z-0959-2.

REASON: The scan carriage may collide with the patient's knees.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by urgent product correction dated April 15, 2002. Firm initiated recall is ongoing.

PRODUCT: All DataCare Systems Software, as follows:

Recall # Z-0960-2/Z-0974-2.

a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200;

b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201;

c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251;

d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252;

e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200;

f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201;

g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206;

h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207;

i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208;

j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251;

k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252;

l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202;

m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209;

n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010;

o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211;

p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212

q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215;

r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216.

REASON: Potential patient/sample mismatch.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on April 1, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft. Recall # Z-0981-2.

REASON: Serodilution of plasma.

MANUFACTURER: MK Manufacturing Forestville, CT. Firm initiated recall is ongoing. Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA, by telephone and letters on March 22, 2002.

PRODUCT: Steel Oxygen Wrench. The device is a Class I steel oxygen wrench.

a) Catalog number 169 has a security wire attached to the wrench.

b) Catalog number 169W does not have the wire.

Recall # Z-0982-2/Z-0983-2.

REASON: Slots may not be big enough to fit on E tanks.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on April 8, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft - Heart Valve. Recall # Z-0984-2.

REASON: Serodilution of Plasma.

CLASS III

MANUFACTURER: Boin Medica Co., Inc, Kumi City, Kyungbuk, Korea.

Firm initiated recall is ongoing. Becton Dickinson & Co. Franklin Lakes, NJ, by e-mail on January 11, 2002.

PRODUCT: Brand Name: Walgreens Sterile Insulin syringes, single use, disposable, 0.3cc and 1.0cc 29 Gauge. Recall # Z-0911-2/Z-0912-2.

REASON: Mispackaged syringes; 3/30cc syringes into 1.0cc syringe boxes.

MANUFACTURER: Philips Medical Systems Nederland, B.V. Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America Company, Bothell, WA, by communication on December 4, 2001.

PRODUCT: Gyroscan NT System, MRI. Recall # Z-0917-2.

REASON: Potential for misdiagnosis. When two images were subtracted, one with contrast and the other without contrast, irregular vessels could be the result on the final image.

MANUFACTURER: Philips Medical Systems Nederland, B.V. 5680 DA Best, Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001.,

PRODUCT: Integris H5000, Angiographic X-ray system.

Recall # Z-0924-2.

REASON: System may occasionally re-boot during a patient examination.

MANUFACTURER: Roche Diagnostics Corp., Mannheim, Germany. Firm initiated recall is ongoing. Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2002.

PRODUCT: LightCycler v1.0; catalog # 2011468. Recall # Z-0925-2

LightCycler v1.1; catalog # 2043912.Recall # Z-0926-2. The device is a medium-sized polymerase chain reaction analyzer for use in industrial, laboratory and domestic setting.

REASON: Glass capillary breakage.

MANUFACTURER: Bausch & Lomb Surgical, Inc., Clearwater, FL, by letter beginning August 31, 2001. Firm initiated recall is ongoing.

PRODUCT: Hydroview brand Intraocular Lens, Posterior chamber lenses, various diopters. Recall # Z-0933-2.

REASON: Lenses were labeled with incorrect dioptic powers.

MANUFACTURER: Macropore, Inc., San Diego, CA, by letter on December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: MacroPore NS CraniLoc Burr Hole Clamp. This is a part of the CraniLoc Cranial Flap Fixation System. Catalog Number: 6692599.

Recall # Z-0934-2.

REASON: Loosening and breakage.

MANUFACTURER: Phillips Medical Systems Nederland, B.V. 5680 DA BEST,

Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America Company, Bothell, WA, by Field Change Order dated September 2001.

PRODUCT: GYROSCAN NT SYSTEM, MRI - Magnetic Resonance Systems.

Recall # Z-0955-2.

REASON: Potential for tabletop (bed) to slide.

MANUFACTURER: Acumed, Inc., Hillsboro, OR, by fax, e-mail or letter on March 7, 2002. Firm initiated recall is complete.

PRODUCT: a) Polarus Humeral Rod, part #HRH-0824-S, 8mm x 240mm.

Recall # Z-0978-2.

b) Polarus Humeral Rod, part #HRH-0826-S, 8mm x 260mm.

Recall # /Z-0979-2.

These implants belong to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation.

REASON: Mislabeled - 240mm Polarus rod labeled as 260mm Polarus rod & vice versa.

MANUFACTURER: Ciba Vision Batam Pulau Batam, Indonesia. Firm initiated recall is ongoing.

MANUFACTURER: Ciba Vision Batam Pulau Batam, Indonesia. Firm initiated recall is ongoing.

PRODUCT: Precision UV (ultraviolet blocking) daily or extended wear soft (hydrophilic) contact lens.

Recall # Z-0980-2.

REASON: Product was distributed without the proper labeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 24, 2002:

CLASS I

MANUFACTURER: Zoll Medical Corp., Burlington, MA, by letter on December 18, 2001. Firm initiated recall is ongoing.

PRODUCT: a) Zoll M Series Advisory Defibrillator.

Recall # Z-0893-2;

b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2.

REASON: Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock.

CLASS II

CORRECTION

On the April 3, 2002 Enforcement Report, Recall # Z 596-2, DynaGraft Gel and Putty, a mixture of human demineralized allograft bone powder mixed with a reverse-phase medium and formulated into a gel or putty consistency was listed as a Class III and it is a Class II.

MANUFACTURER: Guidant Corp., Temecula, CA, by visit, phone and fax on January 29, 2002. Firm initiated recall is complete.

PRODUCT: a) Hi Torque Balance Middle Weight Guide Wire.

Recall # Z-0828-2;

b) Dock Extension Wire. Recall # Z-0829-2.

Guide Wires intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty.

REASON: Sterility compromised.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by mail on January 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

Recall # Z-0830-2.

REASON: Power Supply problems for the monitor may shut down without notice.

MANUFACTURER: Integra Neurocare LLC., San Diego, CA, by letter dated March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Ventrix NL950-V Ventricular Tunneling Pressure Monitoring Kit; consists of a sterile, transducer tipped catheter that is used to continuously monitor intracranial pressure and drain cerebrospinal fluid. Kit includes a trocar, introducer stylet, suture loops, a drill bit and hex wrench. Recall #Z-0831-2.

REASON: Directions have blank pages.

MANUFACTURER: Portex, Inc., Keene, NH, by letter on March 19, 2002.

Firm initiated recall is ongoing.

PRODUCT: Portex Hypodermic NEEDLE-PRO Needle with Needle Protection Device (Small Gauge Safety), Sterile:

a) Catalog No. 4320 (25g x 5/8"). Recall # Z-0832-2;

b) Catalog No. 4322 (26g x 1/2"). Recall # Z-0833-2;

c) Catalog No. 4323 (27g x 1/2"). Recall # Z-0834-2.

REASON: Sterility of the device may be compromised due to a loss of package integrity.

MANUFACTURER: Ciba Vision Corp. Duluth, GA, by telephone on March 1, 2002. Firm initiated recall is ongoing.

PRODUCT: SoftPerm Daily Wear Soft (Hydrophilic) Contact Lens. Recall # Z-0835-2.

REASON: Improper sterilization cycle.

MANUFACTURER: Medi-Tech a division of Boston Scientific Corp., Watertown, MA. Firm initiated recall is complete.

PRODUCT: Boston Scientific/Medi-Tech RENEGADE Hi-Flo Microcatheter Kit. Recall # Z-0836-2.

REASON: Kit packaged with an incorrect quidewire length of 135 cm instead of 165 cm.

MANUFACTURER: Cordia Europa Roden, Netherlands.

Firm initiated recall is ongoing.

PRODUCT: Cordis Temp 4F Diagnostic Catheter WITH THE FOLLOWING CATALOG NUMBERS OR ITEM NUMBERS (SEE CODES SECTION FOR CORRESPONDING LOT NUMBERS UNDER RECALL): 451406H0, 451406H2, 451406P0, 451406P2, 451406S0, 451406S2, 451406V0, 451407H2, 451407S2, 451407V0, 451413H0, 451413V0, 451414H0, 451415H0, 451415V0, 451423H0, 451424H0, 451425H0, 451430H0, 451430H2, 451431H0, 451431H2, 451432H0, 451435H0, 451442V0, 451442V2, 451443H0, 451443V0, 451443V2, 451444V0, 451444V2, 451446S0, 451446V2, 451447S0, 451447S2, 451449V0, 451450V0, 451457V0, Total Items38

Recall # Z-0839-2-0876-2.

REASON: Instances of catheter tip separation.

MANUFACTURER: HemoCleanse, Inc., Rochester, NY. Firm initiated recall is ongoing.

PRODUCT: Liver Dialysis Unit: Treatment Kit/Disposable Pack. Recall # Z-0877-2. This is a disposable, single use kit used during dialysis.

REASON: The filtrate generator was installed backwards, causing tension and crimping in the tubing line.

MANUFACTURER: UMM Electronics Inc., Indianapolis, IN. Firm initiated recall is ongoing.

PRODUCT: Liver Dialysis Unit Machine (LDU1) and Treatment Kits. Recall # Z-0878-2.

REASON: Electronic controller board overheats causing alarm and device failure.

MANUFACTURER: Stryker Trauma GmbH, D24232 Schoenkirchen, Germany.

Firm initiated recall is complete.

PRODUCT: Gray Tip Drill, 1 x 0.126 x 8". Recall # Z-0879-2.

REASON: Gray Tip Drill mislabeled as lag screw.

MANUFACTURER: UMM Electronics, Inc., Indianapolis, IN. Firm initiated recall is complete.

PRODUCT: Liver Dialysis Unit Machines and kits. (aka LDU2) Product was previously named BioLogic DT System with BioLogic DT TK1000 kits. Recall # Z-0880-2.

REASON: Units alarm and shut down for unexplained reason.

MANUFACTURER: Drager Medical AG & Co KGaA Lubeck, Germany.

Firm initiated recall is ongoing.

PRODUCT: Caleo Infant Warming System. The product is an incubator. The device provides access for minor surgical procedures and allows endotracheal incubation without having to slide the baby out of the incubator. Recall # Z-0881-2/Z-0885-2.

REASON: May short circuit.

MANUFACTURER: Acumed, Inc., Beaverton, OR, by fax or e-mail on January 31, 2002. Firm initiated recall is complete.

PRODUCT: a) Polarus Humeral Rod System, part #HCO3275-S, 3.5mm x 27.5mm b) Cortical Screw, and part #HCO3325-S, 3.5mm x 32.5mm Cortical Screw. The Polarus Humeral Rod System is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. Recall # Z-0886-2/Z-0887-2.

REASON: Extended sterilization expiration date.

MANUFACTURER: Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson, AZ, by a temporary procedural workaround March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory for Windows version 5.3.

Recall # Z-0888-2.

REASON: Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results.

MANUFACTURER: Avanta Orthopaedics, Inc., San Diego, CA, by telephone on March 14, 2002. Firm initiated recall is complete.

PRODUCT: Avanta Orthopaedics, Proximal Radial Head Stem, Product Code RHA-S2, Lot RS0099. Recall # Z-0889-2.

REASON: Label mix-up. Incorrect size on label.

MANUFACTURER: Philips Medical Systems Nederland, B.V. 5680 Da Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT: a) Integris Allura X-ray system with Ultrasound option. The Integris Alluras x-ray system is used as an imaging device for: dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures; cardiac imaging applications including diagnostics, interventional procedures, pacemaker implantations, and electrophysiology; non-vascular interventions such as drainage and biopsies. Recall # Z-0890-2;

b) MultiDiagnost 3 with Ultrasound Option.

Recall # Z-0891-2

c) MultiDiagnost 4 with Ultrasound Option. The MultiDiagnost 3 and MultiDiagnost 4 are multi functional/universal systems used for general R/F. Fluoroscopy, Radiography and Angiography can be performed with other specialized interventional applications. The ultrasound system is used for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-0892-2.

REASON: Potential for supporting arm and keyboard to strike patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 17, 2002:

CLASS I

MANUFACTURER: A & A Medical/Rocket USA, (also labeled Lifequest), Alpharetta, GA, by letter on March 13, 2002. Firm initiated recall is ongoing.

PRODUCT: Various OB/GYN surgical devices labeled as sterile or processed by ETO. Recall # Z-0597-2.

REASON: Devices may not have been adequately sterilized.

MANUFACTURER: Proximal Inc., Largo, FL. Firm initiated recall is ongoing.

PRODUCT: Bard RapidFire Multiple Band Ligator.

Recall # Z-0755-2.

REASON: Band Ligator may fail to deploy and prevent control of bleeding.

CLASS II

MANUFACTURER: Fresenius Hemocare, Inc., Redmond, WA, by letters dated September 20, 2001. Firm initiated recall is complete.

PRODUCT: PROSORBA Protein A Immunoadsorption Column - indicated for use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containing circulating immune complexes from plasma in patients with idiopathic thromocytopenic purpura (ITP) having patelet counts less than 100,00mm3. The Prosorba column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDS).

Recall # Z-0782-2.

REASON: Increased potential to develop vasculitis.

MANUFACTURER: Avent SA de CV Nogales, Sonora, Mexico. Firm initiated recall is ongoing.

PRODUCT: a) ORTHOARTS Lower Extremity Drape, Bulk Pack, Non-sterile;

b) ORTHOARTS Lower Extremity Drape, Sterile;

c) ORTHOARTS Lower Extremity Pack, Sterile;

d) ORTHOARTS Hip Drape, Bulk Pack, Non-sterile;

e) ORTHOARTS Hip Drape, Sterile;

f) ORTHOARTS Hip Pack, Sterile;

g) ORTHOARTS Knee Arthroscopy Drape, bulk, non-sterile;

h) ORTHOARTS Knee Arthroscopy Drape, sterile;

i) ORTHOARTS Knee Arthroscopy Pack;

j) Canton-Potsdam Lower Extremity Pack;

k) Mercer Orthopedic II Pack;

l) ORTHOARTS Lower Extremity Pack;

m) Sharon Regional Total Knee Pack.

Recall # Z-0784-2/Z-0796-2.

REASON: The fenestrated elastic film can separate from drape causing a break in sterility.

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, FL, by telephone on Feb. 21, 2002. Firm initiated recall is complete.

PRODUCT: HA threaded Implant 4.0mm X13.0mm Sterile Endosseous Implants for use in Dental Implant Surgery.

Recall # Z-0798-2.

REASON: Implants may not have the labeled hydroxylapatite coating.

MANUFACTURER: First Aid Only, Vancouver, WA, by telephone in Sept. 2001. FDA initiated recall is complete.

PRODUCT: First Aid Only All Purpose First Aid Kit (Item# FA-143C). Recall # Z-0799-2.

REASON: First aid kits were made using a recalled antiseptic spray that may be subpotent.

MANUFACTURER: Visualization Technology, Inc., Lawrence, MA, by letter on Feb. 20, 2002. Firm initiated recall is ongoing.

PRODUCT: InstaTrak Adult Headset (Part No 1000497). Recall # Z-0800-2; InstaTrak Large Pediatric (Part No 1000948). Recall # Z-0801-2;

InstaTrak Small Pediatric (Part No 1000949). Recall # Z-0802-2. The InstaTrak system is intended as an aid to the surgeon for precisely locating anatomical structures anywhere in the human body during either open or percutaneous procedures.

REASON: Use of headset in a rotated position may result in undetected system inaccuracy.

MANUFACTURER: Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2.

REASON: Software anomaly may allow patient results to be transposed against another patient header or identification.

MANUFACTURER: Medtronic, Inc., Minneapolis, MN, by letter dated March 15, 2002. Firm initiated recall is ongoing.

PRODUCT: Kappa 700/600 Dual Chamber (D, DR, and VDD) Implantable Pulse Generator Pacemakers, Models KD700, KD701, KD703, KD706, KDR600, KDR601, KDR603, KDR606, KDR651, KDR653, KDR700, KDR701, KDR703, KDR706, KDR720, KDR721, KDR730, KDR731, KDR733, KVDD700, and KVDD701. Recall # Z-0804-2/Z-0823-2.

REASON: Submuscular implant locations (subpectoral, abdominal, etc.) can result in additional stress and repetitive flexing on the implanted pacemaker, causing excessive fatigue and fracture of internal wires supplying power to the pacemaker.

MANUFACTURER: EURO/DPC, Ltd. Wales, The United Kingdom. Firm initiated recall is ongoing.

PRODUCT: Brand Name: IMMULITE 2000 Anti-Thyroglobulin Antibody Common/ Usual Name: IMMULITE 2000 Anti-Thyroglobulin Antibody, Intended for the quantitative measurement of autoantibodies to Thyroglobulin in serum EDTA and heparinized plasma. Recall #Z-0824-2.

REASON: Insufficient stability at certain temperatures causes control values to be high.

MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA, by telehone on January 30, 2002. Firm initiated recall is ongoing.

PRODUCT: Brand/Common/Usual Name of Device: IMMULITE Anti-TPO

This is an in-vitro diagnostic device. It is supplied in 100 and 500 test kits. Model/catalog numbers are: 100 test: LKT01 175 500 test: LKT05 175.

Recall # Z-0825-2.

REASON: Instability caused positively biased control values.

MANUFACTURER: DeRoyal Surgical, New Tazewell, TN. Firm initiated recall is ongoing.

PRODUCT: DeRoyal Vasectomy Tray, a surgical kit, P/N 50-9112. Recall # Z-0826-2.

REASON: Surgical kits contained recalled Ethicon sutures.

MANUFACTURER: Spembly Medical Ltd., England. Firm initiated recall is ongoing.

PRODUCT: Selector Ultrasonic Surgical Aspirator System; affected part is the Selector Integra Ultrasonic Aspirator Operator's Manual, Part Number: OM 1530000M1; Issue C168-4. Recall # Z-0827-2.

REASON: Directions cite Euro approved not US approved sterilization cycle parameters.

CLASS III

MANUFACTURER: Diagnostic Stago, Taverny, France. Firm initiated recall is ongoing.

PRODUCT: STA-Deficient VIII Immuno-depleted Plasma for Factor VIII: C Assay by STA Analyzers. Recall # Z-0781-2.

REASON: Gradual decline in stability of the reagent after reconstitution.

MANUFACTURER: Louisville APL Diagnostics, Inc., Doraville, GA, by telephone on August 16, 2001. Firm initiated recall is complete.

PRODUCT: Immuclone APhL ELISA Kit (IgG and IgM) calibrators.

Recall # Z-0783-2.

REASON: IgG and IgM calibrators took too long for color reactions.

MANUFACTURER: Cfh Laboratories, L.P., Morris Plains, NJ.

Firm initiated recall is ongoing.

PRODUCT: Unizyme, Recall # Z-0797-2.

REASON: Contamination with brass particles from the tablet press.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 10, 2002:

CLASS II

MANUFACTURER: Cardiovascular Diagnostics, Inc., d/b/a Pharmanetics, Inc., Morrisville, NC. Firm initiated recall is complete.

PRODUCT: PT-One Cards. Recall # Z-0678-2.

REASON: Incorrect inserts were found in some boxes of the product.

MANUFACTURER: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan.

FDA initiated recall is ongoing.

PRODUCT: Pentax brand Video Colonoscopes and Fiber Colonoscopes. The Angle Wire Receptacle component is the affected part. Recall # Z-0680-2/Z-0681-2. Common Names: Video Colonoscope; Fiber Colonoscope Classification Name: Colonoscope (CFR 876.1500).

REASON: Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down).

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by e-mail, letter and notice on January 7, 2002. Firm initiated recall is ongoing.

PRODUCT: Small power chairs and TurnAbout power chairs (510(k) # 972370). Recall # Z-0700-2/Z-0701-2.

The small power chairs include the following product names: Chauffeur Littlest Viva, Chauffeur Littlest Viva Plus, Rascal Model 250, Rascal Model 255, Rascal Model 410, Rascal Model 415, Chauffeur Model 250 and Chauffeur Model 255. The TurnAbout power chairs include the following product names: TurnAbout and TurnAbout Heavy Duty.

These power chairs are personal motorized vehicles intended to provide mobility for individuals, such as the handicapped and the elderly, who are limited in movement.

The power chairs are shipped either covered in plastic or in a brown cardboard unit container labeled with “**MADE WITH PRIDE IN THE USA. *ELECTRIC MOBILITY**”.

The products are labeled with stick-on labels. Labeling information follows.

1. Chauffeur Littlest Viva models are labeled as:

a) “LITTLEST VIVA” in black letters on silver background; and b) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background. The Littlest Viva Plus is also labeled with “plus” in black letters on a silver background.

2. Rascal models are labeled as:

a) “ELECTRIC MOBILITY in gold letters; b) “Rascal” in gold letters; and, depending on the model number, c) either “250 PC”, “255 PC”, “4 10 PC”, or “415 PC” in gold letters.

3. Chauffeur models are labeled as:

a) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background; and, depending on the model number, b) either “250 PC” or “255 PC” in black on a silver background.

4. TurnAbout models are labeled as:

a) “ELECTRIC MOBILITY in gold letters; and

b) “TurnAbout***by Rascal” in gold letters.

REASON: The wheel bolt can loosen and cause the wheel to separate from chair.

MANUFACTURER: Baxter Healthcare Corp. Singapore, SG.

Firm initiated recall is complete.

PRODUCT: Interlink System Continu-Flo Solution Set, 10 drops/ml. approximately, 110" (2.8m), with 3 injection sites and a male luer lock adapter; product code 2C6537W. Recall # Z-0704-2.

REASON: Retrograde flow during direct injection.

MANUFACTURER: Bio-Rad Laboratories, Inc., West Sacramento, CA, by telephone and fax on Jan. 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Helix Diagnostics, Enzyme Immunoassay Helicobacter pylori H. pylori) IgM Test Kits. Recall # Z-0705-2.

REASON: Device marketed without a 510(k) or PMA.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on January 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Haemonetics PCS2 Harness Set, Sterile List Number:620. Recall # Z-0706-2.

REASON: Potential leakage at needle adapter site may expose user to donor blood.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ

PRODUCT: FlexiLab Laboratory Information System. Recall # Z-0710-2.

REASON: Date Format Issue--Flexilab Software converts specimen collect and receipt dates to American standard format 'mm/dd/yyyy'. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect or receipt date.

MANUFACTURER: ANSYS Technologies Inc., Lake Forest, CA. Firm initiated recall is ongoing.

PRODUCT: On-Site Alcohol test kit. Recall # Z-0711-2.

REASON: False negative results or false positive may be reported.

MANUFACTURER: Sims Deltec, Inc. St. Paul, MN, by notification dated Feb. 6, 2002. Firm initiated recall is ongoing.

PRODUCT: PORT-A-CATH II Dual-Lumen Low Profile

Polysulfone/Titanium (Implantable) Venous Access System, with 1.0mm I.D PolyFlow Polyurethane Catheter and 7 French Introducer Set.

Recall # Z-0712-2/0713-2.

REASON: The Wing-Lock catheter connectors of some of the devices will not snap into place as described in the Instructions for Use.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN, by letter dated February 8, 2002. Firm initiated recall is ongoing.

PRODUCT: AngioJet Drive Units (product number 101973-TAB) for the AngioJet Rheolytic Thrombectomy System (AngioJet System), Recall # Z-0714-2.

REASON: Loose hardware can fall on the circuit board producing an intermittent or permanent electrical failure of the Drive Unit.

MANUFACTURER: Medel Italiana Srl Polo di Torrile, Italy. Firm initiated recall is ongoing.

PRODUCT: Comp-Air Elite Rechargeable Battery and DC Auto Adapter for NE-C21 Comp-Air Elite Compressor, Model C21BATKIT; Made in Italy. Recall # Z-0715-2.

REASON: Premature failure of rechargeable battery.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by a Merit employee beginning November 1, 2001. Firm initiated recall is ongoing.

PRODUCT: 1) Merit Manifolds 2) Merit Coronary Control Syringes 3) Merit Fluid Administration Sets 4) Merit Custom Convenience Sets 5) Merit Contrast Management System 6) Merit Disposal Depot 7) Merit Pressure Monitoring Tubing 8) Merit VacLok Syringes.

Recall # Z-0716-2/Z-0723-2.

REASON: Seals on Tyvek/Nylon pouches are potentially defective.

MANUFACTURER: Baxter Healthcare Corporation Cleveland, MS. Firm initiated recall is ongoing.

PRODUCT: Baxter Spinal Anesthesia Trays, product code 1T2356. Recall # Z-0724-2.

REASON: Trays labeled with incorrect expiration date.

MANUFACTURER: Nichols Institute Diagnostics, San Juan Capistrano, CA, by letter dated January 25, 2002. Firm initiated recall is complete.

PRODUCT: Nichols Advantage Thyroglobulin Assay, An in-vitro diagnostic intended for the quantitative mesurement of Thyroblobulin in human serum. Recall # Z-0725-2.

REASON: Dilution result may read less than the 0.9 ng/mL negative out-off.

MANUFACTURER: Deroyal Orthopedic Fabrication, Maynardville, TN.

Firm initiated recall is ongoing.

PRODUCT: Premium Abduction Pillow with Kodel Band; Custom Abductor

Pillow; and 6” Patella Strap. Recall # Z-0726-2/0727-2.

REASON: Undeclared natural rubber.

MANUFACTURER: Sysmex Corporation Kobe, Japan. Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers and Sysmex Automated Reticulocyte Analyzers.

Recall # Z-0731-2/Z-0742-2.

Models:

a) K-4500, Automated Hematology Analyzer, an in-vitro device for use in clinical laboratories to analyze whole blood samples as a screening device for identifying samples with abnormal cells.

b) R-3500, Automated Reticulocyte Analyzer, a fully automated reticulocyte analyzer for in-vitro diagnostic use in clinical laboratories.

c) SF-3000, Automated Hematology Analyzer, an in-vitro device for blood cell analysis in clinical laboratories, as a screening device for identifying samples with abnormal cells. Medical Technologists are responsible for final review of abnormal cells.

d) SE-9000, Automated Hematology Analyzer, 23 parameters, an in-vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells.

e) SE-9500, Automated Hematology Analyzer, 25 parameters, an in-vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells.

f) SP-100, Automated Hematology Slide Preparation Unit.

g) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, intended to classify formed elements in EDTA anti-coagulated blood.

h) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, intended to classify formed elements in EDTA anti-coagulated blood.

i) SE-Alpha, Integrated Hematology System, receives the data from the SE-9000/9500 automated hematology analyzer and directs the SP-100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk-away environment.

j) SE-HST, Total Hematology Automation System, receives the data from the SE-9000/9500 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation.

k) XE-Alpha, Hematology Alpha Transportation System, receives the data from the XE-2100 automated hematology analyzer and directs the SP-100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk-away environment.

l) XE-HST, Total Hematology Automation System, receives the data from the XE-2100 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation.

REASON: Potential misidentification of samples.

MANUFACTURER: TFX Medical Annacotty, Co., Liomerick, Firm initiated recall ongoing.

PRODUCT: Boston Scientific Medi-Tech Imager II 4 Fr Angiographic Catheters in the types and models described below:

Product Description Catalog Numbers

a) 4F/Tennis Racquet .035”/65 cm M001315001

b) 4F Tennis Racquet .035”/90 cm M001315011

c) 4F Pigtail .035”/65 cm M001315091

d) 4F Straight .035”/65 cm M001315101

e) 4F Pigtail .035”/90 cm M001315111

f) 4F Straight .035”/90 cm M001315121

g) 4F Contra .035”/65 cm M001315251

h) 4F Contra .035”/90 cm M001315261

i) 4F Contra .035”/100 cm M001315271

Recall # Z-0743-2/0751-2.

REASON: Catheter tip may separate from the device if significant flexing forces are applied.

MANUFACTURER: Genzyme Corp., Cambridge, MA. Firm initiated recall is ongoing.

PRODUCT: Becton Dickinson's ColorPAC brand Giardia/Cryptosporidium Rapid Assay in-vitro diagnostic kit, packaged in papercard box, each kit containing instructions, reagents and components to perform 30 tests. Recall # Z-0756-2.

REASON: IVD kit may exhibit false positive results.

MANUFACTURER: The Kendall Co. lp, Argyle, NY. Firm initiated recall is ongoing.

PRODUCT: Kendall Mahurkar 12Fr Triple Lumen Catheter Kits and Trays. Recall # B-0757-2/B-07561-2.

REASON: Dialysis catheter connection may crack and cause leakage of fluid.

MANUFACTURER: Specialty Surgical Products, Inc., Victor, MT, by telephone and fax on December 20, 2001. Firm initiated recall is complete.

PRODUCT: Mammary sizer; intraoperative determination for volume of breast implants. Recall # Z-0764-2/Z-0765-2.

REASON: Product mislabeled as sterile when it was non-sterile.

MANUFACTURER: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche/Hitachi Tina-quant IgM. Recall # Z-0768-2.

REASON: Precipitate in r2 bottle causes false high or low results.

MANUFACTURER: Sysmex Corporation of America, Long Grove, IL, by "End

User Bulletin" on January 18 and March 19, 2002.

Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers.

Models:

a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0774-2;

b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L). Recall # Z-0775-2.

REASON: Potential misidentification of samples due to a time out error.

MANUFACTURER: Sysmex Corporation of America, Long Grove, IL, by e-mail to Roche on January 18 and "End User Bulletin" on March 19, 2002. Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers.

Models:

a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0776-2;

b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L).

Recall # Z-0777-2.

REASON: Potential misidentification of samples.

MANUFACTURER: Microsurgical Technology, Inc., Redmond, WA, by telephone on May 8 and letters on June 5, 2001. Firm initiated recall is complete.

PRODUCT: Aspiration tube of I/A stainless steel handpieces part number 10-030. I/A handpieces are used in cataract surgery to aspirate and irrigate the lens cavity. Recall # Z-0778-2/Z-0780-2.

REASON: Leaking aspiration tubes.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, INC. Rochester, NY, by telephone on July 5, 2001. Firm initiated recall complete.

PRODUCT: Vitros Digoxin Slides, for use with Vitros Chemistry Systems to quantitatively measure Digoxin concentration in serum and plasma.

Recall # Z-0025-2.

REASON: Analyzer could produce biased results due to incorrect lot # on barcode.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by correction notice dated November 13, 2001. Firm initiated recall is ongoing.

PRODUCT: All DataCare Systems Software, as follows:

a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200

b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201

c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251

d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252

e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9200

f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201

g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9206

h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9207

i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9208

j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9251

k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9252

l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202

m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209

n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010

o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211

p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212

q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215

r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216.

Recall # Z-0682-2/Z-0699-2.

REASON: Potential patient/sample mismatch.

MANUFACTURER: Micro Motors, Inc. Santa Ana, CA, by telephone and letter on February 28, 2002. Firm initiated recall is ongoing.

PRODUCT: DynaTorq brand Dental Torque Wrench. Recall # Z-0752-2/Z-0754-2.

REASON: Error in torque setting.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter on or about February 7, 2002. Firm initiated recall is complete.

PRODUCT: Hill-Rom Utility Shelf for placement of equipment on the Uniflex headwall. Model P105001. Recall #Z-0762-2.

REASON: Electrical shock hazard.

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific/Medi-Tech:

Vaxcel PICC Peripherally Inserted Central Catheter 6 Fr Dual Lumen Clampable Hub, 130 cm Wire Catalog Number: 45-426. Recall # Z-0763-2.

REASON: Outer Carton is mislabeled as 6 Fr Dual Lumen, inner label correctly identifies product as a 5 Fr Single Lumen.

MANUFACTURER: Microsurgical Technology, Inc., Redmond, WA, by telephone on April 25, 2001. Firm initiated recall is complete.

PRODUCT: Aspiration Slug in the Phaco handpieces - Phaco handpieces are AC-powered devices with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Recall # Z-0766-2/0767-2.

REASON: Burr in aspirator pathway.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated November 27, 2001. Firm initiated recall is ongoing.

PRODUCT: a) Cook Check-Flo Plus Introducer Set, 12 French.

Recall # Z-0771-2;

b) Cook Check-Flo Plus Introducer Set, 14 French.

Recall # Z-0772-2;

c) Cook Check-Flo Plus Introducer Set, 16 French.

Recall # Z-0773-2.

REASON: Valve may move into patient through introducer.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 03, 2002:

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by mailing June 21, 2001. Firm initiated recall is ongoing.

PRODUCT: FlexiLab Laboratory Information System, versions 5.23 and 5.3 with Specimen Management Routing and Tracking (SMART). Recall # Z-0656-2.

REASON: Container ID labels print incorrectly, names of patients mix.

MANUFACTURER: Matrix Technologies Corp., Hudson, NH, by letter dated December 20, 2001. Firm initiated recall is ongoing.

PRODUCT: ID-MTS (Micro Typing System) IMPACT Pipettor. Recall # Z-0667-2.
 

REASON: Motor may fail resulting in inaccurate volume filling and causing a false negative test result.

MANUFACTURER: Manufacturer: Becton Dickinson Microbiology Systems, Cockeysville, MD. Firm initiated recall is ongoing.

PRODUCT: Haemophilus Test Medium Agar, catalog #221954, packaged as plated media, 8 plates per plastic package. Recall # Z-0668-2.

REASON: Micobiological test media may exhibit insufficient growth of bacteria

MANUFACTURER: Beckman Coulter, Inc. Brea, CA, by letter dated February. 8, 2002. Firm initiated recall is a 24- hour alert.

PRODUCT: Beckman Coulter Synchron LX20 Clinical System. This is a machine used to perform clinical chemistry tests on patient specimens. Recall # Z-0670-2.

REASON: Synchron LX20 Low cc side chemistries.

MANUFACTURER: DM Medical, Inc. Cincinnati, OH, by recall notices on February 28, 2002. FDA initiated recall is ongoing.

PRODUCT: Smoke Evacuator Hoses, sterile and non-sterile, single use only. Recall # Z-0671-2/Z-0676-2.

Each hose unit is packaged in a Tyvek bag under the DM Medical label, with a disposable aspirator adapter. The following items are recalled:

Catalog # Description

HA-3